Subject: Letters to the Editor:  FDA:  New-Drug Testing
Date: Published: 8/11/88 33 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Letters to the Editor:  
    FDA:  Ethical Solution
    To New-Drug Testing

    You are certainly right that the Food and Drug
 Administration should drop phase-three testing as a
 requirement for new-drug approval in the case of
 life-threatening diseases such as AIDS ("Decision for the
 Dying," editorial, Aug. 2).  However, this does not mean that
 phase three should be abandoned altogether.  Given the fact
 that the FDA's data show a significant minority of phase-two
 drugs in fact turn out to be ineffective, the proper approach
 may be to continue testing on a post-marketing basis.
    To be sure, the FDA protectionists will claim that it is
 more difficult to find volunteers for double-blind studies
 once drugs are already on the market.  However, the ethical
 solution to this problem is to offer adequate incentives
 (such as special treatment, insurance and financial
 assistance) so that patients volunteer for controlled
 studies, rather than force them to enlist in double-blind
 studies by denying them treatment elsewhere, the extortionate
 final solution of the current FDA system.
    Dale Gieringer
    Oakland, Calif.

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